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EC number: 811-858-8 | CAS number: 2149571-68-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian cell study: DNA damage and/or repair
- Remarks:
- Type of genotoxicity: DNA damage and/or repair
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted following OECD/EU guideline and in accordance with GLP. Study material is well characterized.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 486 (Unscheduled DNA Synthesis (UDS) Test with Mammalian Liver Cells in vivo)
- Deviations:
- yes
- Remarks:
- Only two animals were used for evaluation of the 2-4 hour treated groups due to no cells being present on the slides. Clear negative results mean that the missing animal would provide limited additional data, study integrity is not affected
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- unscheduled DNA synthesis
Test material
- Reference substance name:
- pentasodium 4-amino-3-[(1E)-2-(2,4-disulfonatophenyl)diazen-1-yl]-5-hydroxy-6-[(1E)-2-(4-nitro-2-sulfonatophenyl)diazen-1-yl]naphthalene-1,7-disulfonate
- EC Number:
- 811-858-8
- Cas Number:
- 2149571-68-4
- Molecular formula:
- C22 H11 N6 O18 S5 .5Na
- IUPAC Name:
- pentasodium 4-amino-3-[(1E)-2-(2,4-disulfonatophenyl)diazen-1-yl]-5-hydroxy-6-[(1E)-2-(4-nitro-2-sulfonatophenyl)diazen-1-yl]naphthalene-1,7-disulfonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Test item 206474/B
Identification K1600 black dye
Appearance Black powder
Batch G-173
Purity/Composition 100%(Limit:>98.5% On Dry Basis)
Test item storage At room temperature
Stable under storage conditions until 09 November 2016
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
Administration / exposure
- Route of administration:
- oral: gavage
- Duration of treatment / exposure:
- not applicable
- Frequency of treatment:
- single dose
- Post exposure period:
- 12-16 hours
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
1000 mg/kg
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
2000 mg/kg
Basis:
nominal conc.
- No. of animals per sex per dose:
- 5 males per dose
- Control animals:
- yes, concurrent vehicle
Examinations
- Tissues and cell types examined:
- DNA repair in male rat hepatocytes.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Dose range finding study
In the dose range finding test three males were dosed with 2000 mg K1600 black dye per kilogram body weight. In two animals the hairless body parts were dark coloured within 1 hour after dosing. The next day this staining was disappeared. The other animal showed no treatment related clinical signs or mortality after dosing. Black faeces was observed in the bedding of the cages. The study duration was two days.
On the second day a pilot perfusion was performed with two animals to identify any adverse effects on the liver at this dose level that could interfere with a good performance of the main experiment.
No macroscopic effects in the liver were observed and the viability of the liver cells was 69 and 79%, indicating that hepatotoxicity would not adversely influence the performance of thein vivorat hepatocyte-repair assay.
In vivo rat hepatocyte DNA-repair assay
Based on the results of the dose range finding study and the pilot perfusion dose levels of 2000 and 1000 mg/kg body weight were selected as appropriate doses for thein vivorat hepatocyte-repair assay.
Three male rats were used per sampling time in each treatment group, except for the vehicle and positive control group in whichtworatswereused per sampling time.
The body weights recorded immediately prior to dosing are presented inTable2(APPENDIX1).
Due to unknown reasons the slides of the test item treated animals
(12-16 hours sampling time) could not be used for microscopic
evaluation. Therefore this part of the experiment was repeated.
Mortality / signs of toxicity
The animals of the negative and positive control groups showed no treatment related clinical signs or mortality. In addition the animals dosed with 1000 mg K1600 black dye/kg body weight (2 - 4 hours sampling time) showed no treatment related clinical signs.
Hairless body parts of animals treated with 2000 mg K1600 black dye/kg body weight were dark coloured within 1.5 and 12 hours after dosing (2 - 4 hours and 12 - 16 hours treatment time, respectively). All test item treated animals of the 12 - 16 hours treatment time had black faeces.
Viability of the hepatocytes
At the 2 - 4 hour sampling time,the viability of the hepatocytes, used for the evaluation ofDNArepair inducing ability of K1600 black dye was at least 76% indicating no direct liver toxicity. A mean viability of 89% was found for the vehicle control culture.
At the 12 - 16 hour sampling time, the viability of the hepatocytes, used for the evaluation ofrepair inducing ability of K1600 black dye was at least 53% indicating no direct liver toxicity. A mean viability of 86% was found for the vehicle control culture. In the repeat experiment the viability of the hepatocytes, used for the evaluation ofrepair inducing ability of K1600 black dye was at least 81% indicating no direct liver toxicity. A mean viability of 96% was found for the vehicle control culture.
1.2.3. ResultsDNArepair assay
In all slides used for grain counts sufficient cells of normal morphology to permit a meaningful assessment of unscheduled-synthesis were present. Preparations showed no or slight overt cytotoxicity (e.g. pyknosis£50%).
As a result of oral dosing with K1600 black dye the NNG per coverslip and per animal, as well as the group average revealed no positive response in this assay at any of the dose levels.
The percentage of cells in repair (repair taken as NNG≥5), both per individual animal and for the group average, revealed no increase at any dose.
1.2.4. Acceptability
The NNG in the solvent-treated control cultures was within the historical control data range
Oral dosing of a male rat with dimethylnitrosamine () resulted in a NNG of 45.5 with 100% of the cells in repair (NNG>5). Oral dosing of a male rat with 2-acetylaminofluorene (2-AAF) resulted in a net nuclear grain count (NNG) of 34.5 and 31.7 with 100% of the cells in repair (NNG≥5).
In the scored coverslips the mean background of a single area of the same size as the corresponding nuclear area, located outside the cytoplasm, was always equal to or less than 13 grains, indicating that the autoradiographic procedure functioned adequately.
It can be concluded that the test system was functioning correctly.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
When treated orally with K1600 black dye at doses up to 2000 mg/kg body weight (maximum required dose) male Wistar rats showed no induction of DNA repair in hepatocytes isolated 2 - 4 or 12 - 16 hours after dosing, respectively.
In conclusion, K1600 black dye was not genotoxic in the DNA repair assay using hepatocytes obtained from male rats following in vivo exposure to the test item under the conditions described in this report. - Executive summary:
Evaluation ofrepair inducing ability of K1600 black dye in male rat hepatocytes (in vivorat hepatocyterepair assay).
This report describes therepair inducing ability of K1600 black dye in male Wistar rat hepatocytes, measured as unscheduledsynthesis ().
The study procedures described in this report were based on the most recent OECD and EC guidelines.
Batch G-173 of K1600 black dye was a black powder with a purity of 100% (Limit:>98.5% On Dry Basis). The test item was suspended in physiological saline.
In the dose range finding study male animals were dosed by oral gavage with 2000 mg K1600 black dye per kg body weight. In two animals the hairless body parts were dark coloured within 1 hour after dosing. The next day this staining was disappeared. The other animal showed no treatment related clinical signs or mortality after dosing. Black faeces was observed in the bedding of the cages. The study duration was two days. On the second day a pilot perfusion was performed with two animals dosed with 2000 mg/kg body weight. The viability of the hepatocytes was within the normal range (69% and 79%).
Two groups of 5 male Wistar rats received a single oral dose of 2000 or 1000 mg K1600 black dye/kg body weight for both sampling times (2 - 4 and 12 - 16 hours). Hairless body parts of animals treated with 2000 mg/kg body weight were dark coloured. The animals treated with 1000 mg/kg body weight showed no treatment related clinical signs after dosing. All test item treated animals of the 12 - 16 hours treatment time had black faeces.
Corresponding vehicle treated groups served as negative controls. Hepatocytes of positive control animals treated with single oral doses of dimethylnitrosamine (, 10 mg/kg body weight) or
2-acetylaminofluorene (2-AAF, 50 mg/kg body weight) were harvested 2 - 4 or 12 - 16 hours after dosing respectively. No treatment related clinical signs or mortality were noted in control animals. Two slides per animal and one to two animals for each control group were examined.As a result of oral dosing with K1600 black dye the net nuclear grain count (NNG) per slide and per animal, as well as the group average revealed no positive response in this assay. The percentage of cells in repair (repair taken as NNG≥5), both per individual animal and for the group average, revealed no significant increase at any dose.
The results of the negative and positive controls were within the expected range. Therefore, it can be concluded that the test system functioned properly.
It is concluded that K1600 black dye is not genotoxic in the-repair assay using hepatocytes obtained from male rat liver followingin vivoexposure for 2 - 4 or 12 - 16 hours to K1600 black dye up to concentrations of 2000 mg/kg body weight under the conditions described in this report.
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